Elevated High-sensitivity C-reactive Protein (hsCRP), Obesity
Conditions
Brief summary
This study is being done to look at the efficacy single and multiple ascending dose study investigating safety, tolerability, pharmacokinetics, food effect and target engagement in healthy adults including a single cohort in adults living with obesity. Participants will either get NNC6022-0004, (the treatment being tested) or Placebo (a treatment that has no active medicine in it) and which treatment participants get is decided by chance.
Detailed description
The study consists of 5 Parts (Parts A to E and the participants will be assessed based on the study intervention received (NNC6022-0004 or Placebo).
Interventions
DRUGNNC6022-0004
Participants will receive single dose of NNC6022-0004 administered orally in capsule form.
DRUGPlacebo
Participants will receive placebo matched to NNC6022-0004 administered orally in capsule form.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male, or female of non-childbearing potential. * For Parts A, B, C and D: Age 18-55 years (both inclusive) at the time of signing the informed consent. For optional Part E only: Age 18-65 years (both inclusive) at the time of signing the informed consent. -For Parts A, B, C and D: Body mass index (BMI) between 18.5 to 29.9 kilogram per meter square (kg/m\^2) (both inclusive) at screening. For optional Part E only: BMI between greater than or equal to (≥) 30.0 to less than or equal to (≤) 45.0 kg/m\^2 at screening, or if BMI is between 27.0 and \<30.0 kg/m\^2, waist to height ratio should be greater than (\>)0.5. * Body weight: ≥50.0 kilogram (kg) at screening. * Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator. * For optional Part E only: hsCRP ≥2.00 and ≤8.00 milligrams per liter (mg/L) during screening period in 2 separate samples taken ≥4 days apart.
Exclusion criteria
* Known or suspected hypersensitivity to study intervention(s) or similar products. * Any disorder, unwillingness or inability which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. * Any of the below laboratory safety parameters at screening outside normal range, see designated reference range documents for specific values. * Alanine Aminotransferase (ALT) \> Upper limit of normal (ULN). * Alkaline Phosphatase (ALP) \> ULN. * Aspartate aminotransferase (AST) \> ULN. * Total Bilirubin (TBL) \> ULN. * Creatinine \> ULN. * International normalized ratio (INR) \> ULN. * Fibrinogen outside normal range of 1.6 - 4.2 grams per liter (g/L). * hsCRP \> 5.00 mg/L (males) and \> 8.00 mg/L (females)\*. * applicable for Parts A, B, C and D and for optional Part E: hsCRP \>8.00 mg/L. * Use of prescription medicinal products or vaccines within 14 days before screening and/or non prescription medicinal products within 7 days before dosing. Exceptions are: Topical medications not reaching systemic circulation; less than once per week of over-the-counter paracetamol, ibuprofen and/or acetylsalicylic acid at their labelled doses for mild pain; vitamins at their labelled doses.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part A: Area under the NNC6022-0001 plasma concentration-time curve from time 0 to last measurable plasma concentration (AUC0-tz) after a single dose | From pre-dose (Day 1) until visit 3 (Day 9) | Measured as micromolar per hour (µM\*h). |
| Part A: Maximum observed plasma concentration (Cmax) of NNC6022-0001 after a single dose | From pre-dose (Day 1) until visit 3 (Day 9) | Measured as micromolar (µM). |
| Part B: Number of treatment emergent adverse events (TEAE) | From time of dosing (Day 1) to end of study visit (Day 14) | Measured as number of events. |
| Part C: Number of treatment emergent adverse events | From time of dosing (Day 1) to end of study visit (Day 41) | Measured as number of events. |
| Part D: Area under the NNC6022-0001 plasma concentration-time curve from time 0 to last measurable plasma concentration (AUC0-tz) after a single dose | From pre-dose (Day 1 or Day 8) to end of visit (Day 5 or Day 12) | Measured as µM\*h. |
| Part E: Number of treatment emergent adverse events | From time of dosing (Day 1) to end of study visit (Day 13) | Measured as number of events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part A: The area under the NNC6022-0001 plasma concentration-time curve from time 0 to infinity (AUC0-∞) after a single dose | From pre-dose (Day 1) until visit 3 (Day 9) | Measured as µM\*h. |
| Part A: Number of treatment emergent adverse events | From time of dosing (Day 1) to end of study visit (Day 9) | Measured as number of events. |
| Part B: The area under the NNC6022-0001 plasma concentration-time curve from time 0 to last measurable plasma concentration (AUC0-tz) after a single dose | From pre-dose (Day 1) until visit 3 (Day 9) | Measured as µM\*h. |
| Part B: The area under the NNC6022-0001 plasma concentration-time curve from time 0 to infinity (AUC0-∞) after a single dose | From pre-dose (Day 1) until visit 3 (Day 9) | Measured as µM\*h. |
| Part B: The maximum observed plasma concentration (Cmax) of NNC6022-0001 after a single dose | From pre-dose (Day 1) until visit 3 (Day 9) | Measured as µM. |
| Part B: Proportion of administered dose recovered as unchanged drug in urine (Fe0-72h), calculated as Ae0-72hour/ dose | From dose (Day 1) until 72h post-dose | Measured as proportion of dose. |
| Part C: The area under the NNC6022-0001 plasma concentration-time curve from time 0 to tau (AUCtau) after the last dose | From pre-dose (Day 28) to tau after last dose (Day 29) | Measured as µM\*h. |
| Part C: The maximum observed plasma concentration (Cmax) of NNC6022-0001 after last dose | From pre-dose (Day 28) until visit 3 (Day 35) | Measured as µM. |
| Part C: interleukin β (IL-1β) (ex vivo): ratio of plasma level at time tau after last dose to baseline | From pre-dose (Day 1) to tau after last dose (Day 29) | Measured as ratio |
| Part D: The area under the NNC6022-0001 plasma concentration-time curve from time 0 to infinity (AUC0-∞) after a single dose | From pre-dose (Day 1 or Day 8) to end of visit (Day 5 or Day 12) | Measured as µM\*h. |
| Part D: The maximum observed plasma concentration (Cmax) of NNC6022-0001 after a single dose | From pre-dose (Day 1 or Day 8) to end of visit (Day 5 or Day 12) | Measured as µM. |
| Part D: Number of treatment emergent adverse events | From time of dosing (Day 1) to end of visit (Day 16) | Measured as number of events. |
| Part E: Ratio of plasma level at time tau after last dose to baseline (hsCRP) | From pre-dose (Day 1) to tau after last dose (Day 8) | Measured as ratio. |
| Part E: The area under the NNC6022-0001 plasma concentration-time curve from time 0 to tau (AUCtau) after last dose | From pre-dose (Day 7) to tau after last dose (Day 8) | Measured as µM\*h . |
| Part E: The maximum observed plasma concentration (Cmax) of NNC6022 0001 after last dose | From pre-dose (Day 7) until visit 3 (Day 13) | Measured as µM. |
Countries
Netherlands
Contacts
CONTACTNovo Nordisk
STUDY_DIRECTORClinical Transparency dept. 2834
Novo Nordisk A/S
Outcome results
None listed